As part of an initiative to increase transparency at the US Food and Drug Administration, FDA issued last month a report detailing public comment and outlining 21 draft proposals for improving disclosure policies at the agency. Several proposals related to pharmaceutical manufacturing and the supply chain, including suggestions on disclosure relating to import procedures, inspections, and Warning Letters. In the next phase of its transparency initiative (Phase 3), FDA will consider the input it received from regulated industries in evaluating ways in which FDA can improve transparency and efficiency while reducing costs. Later this summer, FDA plans to issue a report that incorporates Phase 3 draft proposals. All draft proposals will be open to further public comment as the agency evaluates these proposed recommendations. FDA had formed a task force as part of an initiative by the agency to gather and evaluate input on ways it could improve its transparency.
Current system. The May report outlined current import procedures for drugs, food, and other products regulated by FDA. These procedures require importers to file information about the product with the United States Customs and Border Protection and other jurisdictions. FDA is authorized to refuse admission of imported products into the US if the products appear to be adulterated or misbranded. FDA discloses the name of the foreign manufacturer responsible for the refused product, the date of refusal, and the description of the product, as provided by the manufacturer, on the FDA website. The information is updated monthly and can be searched by country of origin or by product.
Public feedback. Public input for these import procedures included a suggestion to require FDA to post all responses, status, and correspondence related to products that are detained at the border as well as those that are subsequently released by FDA. Another suggestion was to post all import refusals by FDA’s Office of Regulatory Affairs (ORA) in a searchable database to allow information about refusals to be searchable by pathogen, year, or country.
In considering these suggestions, “the task force considered whether additional disclosure of information about import procedures will give the public a better understanding of FDA activities to protect the food and medical-product supply,” said the report. The task force raised concerns over whether such disclosure would deter imports in general. It also considered whether further disclosure of information on products detained at the border would be useful because detaining a product at the border does not necessarily result in not admitting the product into the US.
Draft proposal. After considering these issues, the task force issued a draft proposal for public comment on increasing disclosure in its import procedures. The draft proposal asserted that “FDA should disclose the outcome of filer evaluation for importers or third parties working on behalf of importers,” said the report. “Disclosing the outcome of filer evaluations will likely increase accountability among actors in the supply chain,” said the report. The report pointed out that such information could also be helpful for regulatory entities that conduct inspections using a risk-based approach to set priorities in their inspection efforts.
Current system: Public disclosure regarding inspection information by FDA was another important item addressed in the report. FDA currently conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products before approving those products and/or before those products are on the market to determine the establishment’s compliance with FDA regulations. If “objectionable conditions” are observed, FDA issues a Form 483, which lists the name of the firm, the date(s) of the inspection, and the observations made by an investigator during inspection. FDA provides an initial classification of the inspection based on its observations: official action indicated (OAI), voluntary action indicated (VAI), and no action indicated (NAI).
If no enforcement action is considered or after enforcement is concluded, FDA provides the establishment with a final inspection report, an Establishment Inspection Report (EIR), which provides a history of the findings, including any action taken by FDA and/or the establishment, any refusals, voluntary corrections, or promises made by the firm, and copies of the related documents issued to the firm when it received the Form 483. FDA posts Form 483s and EIRs in ORA’s electronic reading room on the FDA website when a high level of public interest is anticipated. FDA redacts non-public information, such as trade secrets, from the inspection before posting it.
Public suggestions. Several suggestions from the public concerned ways to improve the timely posting of these reports. Other suggestions involved using the reports as a means of identifying inspection trends by FDA to better understand “FDA’s concerns that may drive inspectional observations and other citations,” said the report. In assessing these comments, FDA concurred that additional disclosure may provide the public with a better understanding of the supply chain and information about the firms from which they are purchasing products. It also felt that such information would be helpful for companies in their compliance efforts. Balanced against these benefits were concerns that further disclosure of information may be misleading in instances where a Form 483 is issued, but the violations do not affect public health and therefore do not require further action by a firm.
Draft proposals. After weighing these factors, the task force issued a draft proposal recommending FDA to disclose the name and address of the entity inspected, the inspection date(s), type of FDA-regulated product involved in the inspection, and the final inspectional classification (i.e., OAI, VAI, NAI) for inspections of clinical trial investigators, Institution Review Boards, and facilities that manufacture, process, pack, or hold, any FDA-regulated product that is currently marketed. The draft proposal is not specific about the timing of when this information should be disclosed but only asserts that “disclosure of this information should be timed so as not to interfere with planned enforcement actions,” according to the report.
In issuing the draft proposal, FDA asserted that disclosing information about inspections increases public understanding, increases accountability by firms, creates incentives to correct violations, and provides other firms with an understanding of compliance issues. Following up on the latter point, FDA issued another draft proposal to require FDA to generate and share information with the public about the most common inspectional observations with objectionable conditions or practices that are made during FDA inspections and to post that information online on a regular basis.
Current system. Related to how FDA should disclose inspection reports and the findings from these reports is how FDA should disclose Warning Letters, which are issued for violations that may lead to enforcement action if not promptly and adequately corrected. FDA currently posts Warning Letters on its website. If FDA can determine that a firm has fully corrected violations raised in its Warning Letter, it will issue an official “close-out” notice that also will be posted online. If requested by the recipient of a Warning Letter, FDA will allow the company or individual to post a response to the Warning Letter. FDA also issues untitled letters, which are used for violations that do not meet the regulatory significance of violations in a Warning Letter, meaning alerting a company to enforcement action if the violation is not corrected.
Public input. Individuals and consumer groups suggested that all FDA Warning Letters and untitled letters be disclosed. The rationale was that the public should know what firms FDA determined to be in violation and the agency’s reasoning for citing the violations. In considering these suggestions, FDA said such information is helpful for the public at large and helps to improve accountability among companies. The agency, however, raised concerns over the volume of this information, particularly the value of disclosing all untitled letters, which may be sent for relatively minor violations.
Draft proposal. After considering these matters, FDA issued a draft proposal to require that the agency post untitled letters on the FDA website, and if requested by the recipient of the letter, a firm’s or individual’s response. In issuing the proposal, FDA concluded that public disclosure is helpful for the public at large and in overall compliance efforts.
The FDA task force has given the public until July 20, 2010, to respond to these draft proposals and the other ones cited in its report. In soliciting these comments, FDA is also asking the public to consider which proposals should be given priority and the tools, techniques, and processes that the agency can use to improve transparency and efficiency while reducing costs. Based on this input, the task force will make specific proposals to the commissioner of FDA.
As a final phase, during this summer, FDA will consider comments relating its transparency initiative to regulated industries. FDA had issued a notice and received comments in April 2010 on ways in which FDA could improve transparency to regulated industry and foster a more efficient and cost-effective process. Similar to how it evaluated comments from the public in making the draft proposals last month, the agency will consider the input from industry when making further draft proposals. The agency will solicit further comment on all draft proposals.